Journal of Pharmacology and Toxicology1816-496x2152-100xAcademic Journals Inc.10.3923/jpt.2009.291.299TamtaA. ChaudharyM. 8200948The present study investigated safety/toxicity profile of Sulbactomax (Ceftriaxone-Sulbactam for injection), a fixed dose combination, in Mus musculus mice and SD rats at three dose levels, 10, 50 and 150 mg kg-1 ranging from asymptomatic to high dose. Sulbactomax was introduced in order to enhance the antimicrobial efficacy and to combat resistance towards beta-lactamase producing bacteria. The combination has been reported to be highly effective as well as synergistic for many resistant strains and carry the potential for its usage in empirical therapy for various bacterial infections. To establish the safety profile of combination, 28 days repeated dose sub-acute toxicity study was conducted on mice and rat (male and female). Various hematological parameters were studied in addition to physiological and biochemical parameters in order to study toxicity profile of Sulbactomax. There were no signs of toxicity observed at any of the dose levels used in this study. Animals from control and different treated groups exhibited normal body weight gain throughout the dosing period of 28 days. No mortality was observed in any of the treatment groups during the course of whole study. Hematological as well as biochemical parameters were unaltered at all three dose levels in Sulbactomax treated rat and mice. From the present study, it can be concluded that Sulbactomax (the fixed dose combination of Ceftriaxone -Sulbactam) is safe even at the dose level which is several folds of the intended human dose.]]>Banerjee, B.N., R.D. Sofia, N.J. Ivins and B.J. Ludwig,19792911411145Betrosian, A.P., F. Frantzeskaki, A. Xanthaki and E.E. Douzinas,200856432436Bhattacharjee, A., M.R. Sen, P. Prakash and S. Anupurba,200861309314Bonfiglio, G., V. Carciotto, G. Russo, S. Stefani, G.C. Schito, E. Debbia and G. Nicoletti,199841307310Brinas, L., M. Lantero, I. de-Diego, M. Alvarez, M. Zarazaga and C. Torres,20055611071110Bradley, J.S., LS. Compogiannis, W.E. Murray, M.A. Acosta and G.L. Tsu,199211961964Carmeli, Y., N. Troillet, A.W. Karchmer and M.H. Samore,1999Pseudomonas aeruginosa.]]>15911271132Caron, F.L., A. Gutmann, B. Bure, J.M. Pangon, A. Vallois, Pechinot and C. Carbon,1990Klebsiella pneumoniae producing extended-broad-spectrum TEM-3 β-lactamase.]]>3420702074Corbella, X., J. Ariza, C. Ardanuy, M. Vuelta and F. Tubau et al.,19982793802Bohmer, E., A., Ribeiro, A.M. Correa, D.G. de-Souza and L. Knorr et al.,20092009Foulds, G., J.P. Stankewich, D.C. Marshall, M.M. O-Brien, S.L. Hayes, D.J. Weidler and F.G. McMahon,198323692699Goldstein, F.W., Y. Pean, A. Rosato, J. Gertner and L. Gutmann,199332595603Goldstein, F.W., Y. Pean and J. Gertner,19953925162519Jacoby, G.A. and A.A. Medeiros,19913516971704Kikuchi, K., T. Tomita, H. Moriyama and K. Totsuka,2002422730Kalender, S., F.G. Uzun, D. Durak, F. Demir and Y. Kalender,20092009Kitzis, M.D., D. Billot-Klein, F.W. Goldstein, R. Williamson and T. Van et al.,198832914Lambert, P.A.,2002Pseudomonas aeruginosa.]]>952226Levin, A.S.,20028144153Li, X.Z., D. Ma, D.M. Livermore and H. Nikaido,1994Pseudomonas aeruginosa: Active efflux as a contributing factor to β-lactam resistance.]]>3817421752Miro, E., F. Navarro, F. March, F. Sanchez and B. Mirelis,199514731732Nechifor, M., D. Buiuc, E. Diaconu, A. Poiata and E. Teslariu et al.,1992965155Ogtrop, V., M.L. Mattie, H. Guiot, H.F. van and E. Strijen et al.,19903419321937Ripa, S., L. Ferrante and M. Prenna,199036185192Sauve, E., P. Azoulay-Dupuis, C. Moine, V. Darras-Joly, C. Rieux, J. Carbon and P. Bedo,19964028292834Shrivastava, SM., S. Saurabh, D. Rai, V.K. Dwivedi and M. Chaudhary,200947377Tikoo, K., A. Tamta, I.Y. Ali, J. Gupta and A.B. Gaikwad,20081779096Walz, D.T., M.J. DiMartino, J.H. Kuch and W. Zuccarello,1971136907910